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There is a special kind of optimism—some might call it magical thinking—that animates the modern failure-to-warn claim against prescription drug manufacturers. It goes something like this: Yes, the FDA-approved label warned about the exact risk that happened to me, but the manufacturer still failed to warn.

Which is a pretty accurate summary of plaintiff’s argument in True v. AbbVie, Inc., 2025 WL 3560299 (N.D. Ga. Sep. 9, 2025). Let’s start with the inconvenient truth (sorry, True)–prescription drug labels are not written by vibes. They are the product of exhaustive clinical data, regulatory scrutiny, and FDA approval. When a label says, in plain English, that a drug carries a risk of X, and X is exactly what happened, it is difficult to argue—without blushing—that the manufacturer failed to warn. But that is exactly what plaintiff True did.

Plaintiff was prescribed an eyedrop to treat her presbyopia—not a disease so much as a rite of passage for anyone over forty or the time when your arms become mysteriously too short.  The active ingredient in the drug is pilocarpine hydrochloride, a member of a class of drugs called miotics. The label on the eyedrops plainly states that retinal detachment has been reported with the use of miotics.  Plaintiff used the drops as directed and within several weeks suffered retinal detachment. Her suit alleges claims for strict liability design defect, strict liability failure to warn, and negligence. Defendants moved to dismiss all claims.  

As the court explains in True, the approval of a New Drug Application (“NDA”), is an “onerous and lengthy” process, that includes the approval of the exact text of the approved label.  Id. at *4. Once approved, a drug manufacturer cannot unilaterally change a product’s label and warnings—with one narrow exception. The “changes being effected” (“CBE”) regulation allows a manufacturer to add or strengthen a warning without prior FDA approval where there is “newly acquired information about the evidence of a causal association between the drug and a risk of harm.” Id.  So, to avoid conflict preemption, a plaintiff must plausibly allege that there is a warning deficiency that the manufacturer could have corrected using the CBE process.

None of the information plaintiff cited to qualified as “newly acquired” information of a new or greater risk. She cited medical literature, case reports, and clinical studies. But none indicated that the risk of retinal detachment is any more severe or frequent than the risks already reviewed by the FDA and warned of in the labeling. Plaintiff also tried to rely on adverse event reports reported in the FDA reporting database (FAERS). But numerous courts, including True, hold that FAERS data is not newly acquired information that would support a CBE label change absent evidence of a causal association between the drug and the risk. Id. at *5. Even the FDA cautions that adverse event reports are not conclusions or admissions “that the drug caused or contributed to an adverse effect.” Id. (citing 21 CFR § 314.80(1).  

Without evidence of a causal link, the best plaintiff could do was put together a graph showing an uptick in adverse event reports. But the plaintiff provided no context, no time parameters, no explanation as to how the graphs demonstrated newly acquired information. Finally, plaintiff argued that defendant could have warned about the risk via its sales representatives and promotional materials, but the allegations of the complaint rest “solely on the inadequacy of the FDA-approved Label.” Id. at *6. Since the argument was “disconnected” from the allegations of the complaint, it could not save plaintiff’s failure to warn claim.

Failure-to-warn claims like this implicitly assume the manufacturer had a legal obligation to do the impossible: change an FDA-approved warning without legal authority to do so. Federal preemption exists precisely to prevent juries from deciding that drug manufacturers should have ignored federal law and rewritten labels on their own initiative.

The court also summarily dismissed plaintiff’s design defect and negligence claims. Plaintiff did not defend either cause of action. Plaintiff’s only design defect claim went to the drug’s formulation which the manufacturer cannot change without FDA approval. Therefore, like failure to warn, it was preempted. Id. To the extent plaintiff’s negligence claims were premised on the same design and warning allegations, they also failed. Id. at *7-8. Which left only negligent failure to research and test which Georgia law does not recognize as an independent cause of action. Id. at *8.   

Because plaintiff’s claims were either preempted or failed as a matter of law, the case was dismissed with prejudice.

And while we always celebrate a preemption win, we can’t overlook that in this case, the label warned of the risk; the risk occurred. End of story. Or at least it should be. The subtext of a claim like this is not that the warning was absent, but that the plaintiff wishes it had been more reassuring. The truth is that a warning can be adequate even if the risk materializes. Warnings are not guarantees. They are disclosures. And when a label discloses the very risk at issue, the failure-to-warn claim should collapse under the weight of its own contradiction.

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It’s been a been a while – some five years – since we discussed cross-jurisdictional class action tolling.  That’s mostly because, aside from the occasional result-oriented atrocity that occurred in the Valsartan MDL, class actions are no longer a top-shelf problem in prescription medical product liability litigation.  But it’s still nice to report on a major appellate decision from a large state giving that novel theory the boot.

That’s precisely what happened in on Halloween in Ackerman v. Arkema, Inc., 157 F.4th 715 (5th Cir. 2025).  Ackerman involved allegations of environmental pollution, not prescription medical product liability litigation.  Shortly after the event, some attorney purporting to represent residents filed a class action in federal court seeking both damages and injunctive relief less than a month after the explosions that allegedly caused the pollution.  Id. at 716.  The federal district court only certified the class for injunctive relief – hardly what the lawyers were primarily after – since monetary relief for different property damage claims isn’t the sort of common injury that supports a class action.  Id.

In 2024, some two years after the injunctive class settled, “800 members of [that] class filed individual actions in Texas state court seeking monetary damages.”  Id.  These claims were admittedly filed “almost six years after they had accrued,” long after the applicable two-year statute of limitations had expired.  Id.  But the plaintiffs claimed that the federal class action – which had never been certified as to property damage claims – somehow trumped the Texas statute and tolled Texas state-law claims brought in  state court.

That’s called “cross-jurisdictional class action tolling,” and Texas (like most states) had never permitted a class action filed in some other court system (here, a federal court) to toll its own statute of limitations in its own courts.  After these 800 claims were removed on diversity grounds to federal court, the trial court rejected their tolling arguments “because Texas law does not recognize cross-jurisdictional tolling of the statute of limitations.”  Id.

The Fifth Circuit has affirmed, rejecting the plaintiffs’ proposed reliance on “policy considerations” to justify their claimed federal procedural impingement on the Texas state statute of limitations.  As our cross-jurisdictional class action tolling scorecard indicates, while the issue has never reached the Texas Supreme Court, state and federal appellate courts have unanimously rejected such tolling.  See Bell v. Showa Denko K.K., 899 S.W.2d 749, 757-58 (Tex. App. 1995); Newby v. Enron Corp., 542 F.3d 463, 472 (5th Cir. 2008); Vaught v. Showa Denko K.K., 107 F.3d 1137, 1147 (5th Cir. 1997).  Adhering to this “binding precedent,” Ackerman, refused plaintiffs’ invitation to expand Texas law.  157 F.4th  at 717.  “state rules for tolling are based on state, not federal, law,” thus “Texas courts would not toll the state statute of limitations in light of a federal class action.”  Id. at 718 (citation and quotation marks omitted).

Plaintiffs “policy” claims were simply reprises of arguments that prior decisions had already considered and rejected:

Appellants’ arguments that there are exceptions to this bar on cross-jurisdictional tolling − such as when certain types of claims are at issue or when defendants have fair notice of the claims − are unavailing.  Newby considered and rejected such arguments, expressly abrogating district court cases holding that Texas courts would allow cross-jurisdictional tolling for property-related claims or where defendants had fair notice.  In the absence of any subsequent Texas decisions rendering our Erie guesses in Vaught and Newby clearly incorrect, we adhere to their holdings.

Id.  Nor was cross-jurisdictional class action tolling a “close question” that would warrant certification to the Texas Supreme Court where neither party sought such relief.  Id. at 718 n.2.

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We recently attended the ACI Drug & Medical Device Seminar in New York, where we always enjoy catching up with old friends, making new acquaintances, and hearing what’s new in our drug and device sandbox.  This year we spoke on the extensive and active litigation that is currently going on over the 340B drug pricing program.  We product liability litigators don’t often focus on drug pricing, but litigation over 340B discounts has become big enough that it has grabbed our attention, in a major way.  The stakes are substantial:  Spending under the 340B program was estimated at $66 billion in 2023, and it is expected to become the largest federal prescription drug program by 2028. 

Today we provide an update on litigation over the use of “contract pharmacies” to dispense prescription drugs purchased at steep 340B discounts.  We described the contours of that litigation here and here, and the latest development is from a lawsuit challenging Utah’s law mandating that manufacturers sell medicines at 340B discounts to unlimited numbers of pharmacies.  In Abbvie, Inc. v. Brown, No. 2:25-cv-00271, 2025 U.S. Dist. LEXIS 228160 (D. Utah No. 19, 2025), a federal court in Utah recently ruled that federal law preempts Utah’s contract pharmacy law and also that the Utah law enacted an unconstitutional taking. 

To recap, prescription drug manufacturers who want to participate in Medicare and Medicaid spending have to offer drugs under the 340B program at steep discounts to certain safety net healthcare providers—so-called “covered entities.”  Because not all covered entities have in-house pharmacies, they are allowed to contract with outside pharmacies to dispense medicines to their patients.  These “contract pharmacies” are thus eligible to purchase drugs at the 340B discounted prices.  For a variety of reasons, the use of contract pharmacies has exploded over the last 15 years, and many manufacturers have concluded, with substantial justification, that this exponential growth threatens the integrity of the program.  So, several of them have tried to apply the brakes by imposing reasonable limitations. 

Multiple states have struck back by passing laws mandating that manufacturers continue to sell 340B discounted drugs to unlimited numbers of pharmacies—including Utah.  In Brown, a group of prescription drug manufacturers sued to enjoin Utah’s law under which manufacturers are not allowed to limit delivery of discounted drugs to contract pharmacies, nor can manufacturers require the submission of claims data or other information as a condition of delivery.  2025 U.S. Dist. LEXIS 228160, at *12-*13. 

In challenging that law, the manufacturers argued (1) that federal law preempts the Utah law, (2) that the Utah law enacted an unconstitutional taking, and (3) that the Utah law violates Due Process and the Commerce Clause.  In denying the state’s motion to dismiss, the district court agreed with the manufacturers on preemption and the Takings Clause.  On preemption, the district court observed that the federal 340B statute did not necessarily occupy the entire field.  But regardless, the Utah statute conflicted with federal law because the Utah statute permits the transfer of drugs at 340B prices to entities that do not serve vulnerable populations.  As the court observed, “under [the Utah statute], entities that potentially do not dispense drugs to patients at all may acquire . . . drugs at 340B prices.”  Because that is “directly contrary” to the 340B program’s purpose, federal law preempts the state law.

On takings, the manufacturers argued that the Utah statute forced them to transfer property for the benefit of private parties “without serving any valid purpose,” including allowing diversion of drugs to ineligible providers.  The district court agreed.  Sure, the manufacturers’ participation in the 340B program is voluntary, but they did not voluntarily accede to the wider parameters imposed by Utah’s law.  In other words, Utah “may not broaden the bargain by riding the coattails of a federal benefit.”  Id. at *28.

The district court did, however, grant the state’s motion to dismiss the manufacturers’ claims based on the Due Process Clause and Commerce Clause.  On due process, the statute’s language—and particularly its use of the terms “interfere” and “pharmacy”—were not so vague as to make the law unconstitutional, and although the statute did not expressly include a scienter requirement, its penalties provision included one by referenced to another law.  Id. at *28-*33.

Finally, the manufacturers’ Commerce Clause failed because, even though Utah’s statute had extraterritorial effects, “[s]tates retain authority under their general police powers to regulate matters of legitimate local concern, even though interstate commerce may be affected.”  Id. at *33.  The Utah statute is limited in application to pharmacies in Utah, and the manufacturers did not allege facts demonstrating discrimination against other states. 

This is a good outcome for prescription drug manufacturers, but it is not the last word.  Stay tuned. 

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There are two main issues that make the eyes of your dutiful Drug and Device Law bloggers well up in frustration over In re Taxotere (Docetaxel) Eye Inj. Prods. Liab. Litig., No. 3023, 2025 U.S. Dist. LEXIS 233514, 2025 WL 3442731 (E.D. La. Dec. 1, 2025).

The first is a gut-level, “this is an example of something wrong with our civil justice system” point:

There have been thousands of lawsuits filed in two MDLs (MDL-2740 and MDL-3023) stretching back nearly a decade and involving the chemotherapy drug Taxotere—which is essential for the treatment of certain breast, lung (non-small cell), prostate, stomach (gastric), and head and neck cancers.  The newer MDL involves allegations that the Taxotere label did not provide full and detailed enough warnings about a potential risk that the drug might make patients cry; the earlier Taxotere MDL involved allegations that this chemotherapy drug caused hair loss. 

For the new MDL, the label warned of “excessive tearing which may be attributable to lacrimal duct obstruction,” but in the plaintiffs’ lawyers’ opinion, this warning also should have said that the “excessive tearing” was due to “stenosis” and patients should specifically consult “a lacrimal specialist at the first sign of excessive tearing.”

Got that? The drug label advised oncologists that their cancer patients might have “excessive tearing” due to tear “duct obstruction,” but because the label did not also say that the cause of the excessive tearing was “stenosis” and to immediately consult a “lacrimal specialist,” we have an MDL, thousands of lawsuits, and almost a decade of obscenely expensive litigation grinding on, with only the lawyers involved reaping anything other than minimal benefit.

Is it any wonder why we generally favor a high-regulation/low-litigation model?  (Or, at least we do when the regulators are actual scientists and doctors who follow the standards of those respective professions. Ahem.)

Which brings us to the second issue, preemption.

The Fifth Circuit already has had to correct the Taxotere MDL District Court once regarding preemption, in a case arising from the hair loss MDL, Hickey v. Hospira, Inc., 102 F.4th 748 (5th Cir. 2024). As Bexis explained about that decision, Taxotere came onto the market through the so-called “paper NDA” process, 21 U.S.C. §355(b)(2). In this earlier Taxotere decision, the Fifth Circuit rejected the District Court’s conclusion otherwise, and held that PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) applied just the same for paper NDA medications as for any other. Thus, because of federal preemption, plaintiffs cannot challenge the sufficiency of a drug’s label warning unless they can show that the manufacturer had “newly acquired” information that “reveal[ed] risks of a different type or greater severity or frequency than previously included in submissions to FDA” such that the manufacturer could have initiated a label change using the changes being effected (or “CBE”) regulation, 21 C.F.R. § 314.70(c)(6)(iii).

In fact, Hickey went further, and reviewed five items of medical literature that supposedly formed the “newly acquired information” that supposedly gave rise to a duty on the part of the Taxotere manufacturer to add the plaintiff-lawyer proposed language about hair loss.

According to the Fifth Circuit, four of the five items of medical literature identified by the plaintiffs could not constitute newly acquired information as a matter of law on the appellate record because they failed to meet the “different type or greater severity or frequency” requirement for the CBE regulation to apply, and because the overall degree of risk was essentially the same.

As to the fifth item of “medical literature”—an “abstract,” not even a full-fledged study—the Fifth Circuit left the door open by only the slimmest of cracks, remanding to the District Court to reconsider this evidence using the proper legal standard.

In this newest In re Taxotere preemption decision, from the excessive tearing MDL, the plaintiffs and District Court plowed through that narrow opening like the door wasn’t even there.

Once again, the manufacturer moved for summary judgment, arguing (similar to the argument in Hickey) that plaintiffs’ claims are preempted because it could not have invoked the CBE regulation—that no “newly acquired information” existed to justify a unilateral label change.

The District Court held that the manufacturer bears the ultimate burden of persuasion on preemption (but deferred whether the plaintiffs bear a limited burden of production to identify evidence of newly acquired information, because the plaintiffs here in fact did that).

The District Court also held that the question of whether information constitutes “newly acquired information” is a matter of law for the judge, not the jury and, as a result, expert testimony on that “ultimate issue” is inadmissible.

Because of this, the District Court’s entire decision—that the manufacturer did have newly acquired information of the necessary import to require a label change—is based entirely on its own assessment of the significance of one small study (the 2003 Esmaeli Cancer Study), without consideration of the affidavit by that study’s author, Dr. Bita Esmaeli, submitted by the manufacturer.

What makes all this troubling is that the District Court makes some pretty dramatic claims about the medical significance of the 2003 Esmaeli Cancer Study, even though that study was really small (it only involved 148 patients), and was duplicative of pre-label approval studies (the 2001 Esmaeli Article and the 2000 Kneuper Hall Abstract) that, as the District Court itself says, “reported on similar injuries and surgical interventions and penned similar warnings regarding the need for referral to an ophthalmologist and/or prompt intervention.”

There is a lot we can say about the significance, or lack thereof, of the conclusions of the 2003 Esmaeli Cancer Study, but the most notable thing the District Court seemed to miss is that, if anything, the study showed that the alleged condition (lacrimal duct obstruction due to stenosis) appears more common in use of Taxotere at a higher, off-label dosage (weekly instead of every three weeks)—in other words, how oncologists would use Taxotere for sicker cancer patients.

Thus, this single, small, repetitive study reflects, at most, new information reflecting a risk of a “different type or greater severity or frequency” regarding excessive tearing for the sickest cancer patients, and nothing about new information for most Taxotere patients receiving the usual treatment doses at the usual pace.  That matters because (at least, perhaps, until further review by the Fifth Circuit), the only Taxotere MDL plaintiffs who should have a non-preempted failure to warn claim are those that received the higher dosage.

And these plaintiffs will still have to prove warnings causation—that their treating oncologists would have declined to prescribe chemotherapy to them as cancer patients, had those oncologists only known about the incrementally different language of the plaintiffs’ lawyers proposed excessive tearing warning. Which, in a non-insane world, should be something very difficult to prove. How many physicians are going to testify, “Correct, I would not have prescribed potentially life-saving chemotherapy to this very sick cancer patient had I only been formally instructed that the excessive tearing due to duct obstruction was because of stenosis, and that a lacrimal specialist consult should be considered.”

Which brings us back to our first point—does this litigation make any sense?

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If it’s Wednesday, it’s plainly time to talk about removal. Today’s case, In re Depo Provera Prods Liab. Litigation, 2025 WL 3252445 (N.D. Fla. Nov. 13, 2025), upholds one of the defense bar’s favorite procedural maneuvers,snap removal. The case was snapped in California, in the Ninth Circuit, and transferred to the Multidistrict Litigation in the Eleventh Circuit.  There was complete diversity (no party on one side of the v shared citizenship with anyone on the other side), and the case was removed before a forum defendant was served.  That should be, and was, a plain case of proper snap removal. 

Just as plain was the fact that the plaintiff did not help her case by never serving the forum defendant, even after removal to federal court.  The plaintiff moved to remand the case to state court, relying on the old chestnut that federal courts are courts of limited jurisdiction. But even with the principle that federal jurisdiction is narrowly construed, the relevant statute plainly allows snap removals, as three circuits (Second, Third, and Fifth) have held, and another (Sixth) had so indicated in a footnote.  Here, the court noted that other courts within the Eleventh Circuit had “come out both ways regarding the propriety of snap removal.”  At the same time, there was some language in an Eleventh Circuit case that “strongly suggests” that “absent gamesmanship on a removing defendant’s part, the Eleventh Circuit believes the statute means what it says.”  

We’re not sure what amount of “gamesmanship” could overcome the plain — there’s that word again — language of 28 U.S.C. section 1441(b)(2)). Snap removal is “at least rational,” and its result does not bump against the “absurdity bar.” In any event, no such gamesmanship was hinted at in this case. 

Accordingly, the court denied the remand motion. That is plainly the right result. 

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There’s a saying that “everyone is entitled to their day in court.” Fair enough. But, to have your day in court, you have to have standing. While the requirements for standing vary from jurisdiction to jurisdiction, all courts require a plaintiff to have suffered an injury in fact. Afterall, the entire idea of standing is to ensure courts handle real disputes—not speculative ones based on things that could, might, or possibly, if the stars align, go wrong. If plaintiffs without injuries can sue, then courts become astrologers, predicting future diseases like they are reading tea leaves. Standing exists because courts deal with facts, not probabilities that sound like they were calculated on a napkin.

In toxic-exposure cases, however, there is a category of plaintiffs who want to treat the courthouse like a medical clinic with a very generous insurance plan. These are individuals who seek medical monitoring because they were exposed to a chemical but experienced no actual physical injury. Not a rash, not a cough, not even an impressively dramatic fainting episode. Fortunately, in line with the growing trend, Colorado recently became the fifth state in a row where an appellate court expressly rejected no-injury medical monitoring claims.

Smith v. Terumo BCT, Inc., — P.3d –, 2025 WL 3029699 (Co. Ct. App. Oct. 30, 2025), is not a drug or device case, but it is adjacent. Defendants sterilize medical equipment using ethylene oxide (EtO), a known carcinogen. Plaintiff filed a purported class action on behalf of individuals who resided near defendants’ facilities alleging they had been injured by exposure to EtO emissions. The purported class explicitly excluded anyone who had been diagnosed with cancer due to EtO exposure, creating a class of individuals who were only alleging an increased risk of cancer or other illness in the future and seeking to be awarded the costs of diagnostic testing for early detection. Id. at *1.

The trial court dismissed the case for lack of standing. After which time, the procedural history gets a little complicated. But in short, plaintiff did not appeal the original order but instead filed a motion for leave to file an amended complaint. That motion went unruled on for three years. In which time we should note that, fortunately, plaintiff remained injury free. Finally, the court denied the request for several reasons, including that amendment would be futile because plaintiff did not cure the legal deficiencies that caused the court to dismiss the complaint in the first place—still no injury in fact, still no standing.  Id. at *2.

The appellate court’s reasoning and conclusion were simply stated:

One of the basic principles of law is that a party may not recover damages if he has not suffered an injury.  Consistent with this principle, a person cannot pursue a tort claim for future death, future physical injury, or future property damage. [An] allegation that EtO exposure increases [the] risk of cancer or other disease amounts to nothing more than a hypothetical claim of future physical injury. . . .

In recent years . . . courts throughout the country have repeatedly held that a toxic tort claim cannot proceed in the absence of a present physical injury. Because these cases are consistent with Colorado‘s longstanding rejection of tort claims based on the potential of future physical harm, the district court did not err by following them.

Id. at *6-7 (citations to other state appellate decisions rejecting medical monitoring claims) (emphasis original).

In other words: you can’t recover for harm you haven’t suffered. It’s the legal version of “no dessert until after dinner.” Plaintiffs asking for medical monitoring without an injury are basically saying, “I haven’t gotten sick, but I’d like to get paid just in case I might someday.” Future illness is speculative by definition and damages based on pure speculation don’t belong in the legal system.

The court addressed two additional arguments. First, plaintiff tried to get the court to adopt the Restatement (Second) of Torts definition of bodily harm which makes mention of a change to the structure of any part of the body even if that change causes no other harm. Restatement 2d, §15. So, plaintiff claimed that the EtO had been “absorbed” and “distributed” in his body constituting a “change in the structure of his body.” Id. at *7.  No Colorado court has ever adopted that definition of bodily harm, and the Smith court decided it need not tackle the question because plaintiff’s claims were conclusory. “[A]bsorption and metabolization do not necessarily lead to changes in the body’s structure or function.” Id. Because plaintiff had no specific allegations that he or any other named plaintiff was experiencing a “currently existing adverse event”, the court rejected the claims as conclusory.

Second, plaintiff argued that medical monitoring was an economic injury. But that argument “blurred the line between establishing injury and damages.” Id. A plaintiff has to demonstrate both a present physical injury and economic losses that result from that injury. You can’t just jump to damages and bypass injury.

At the end of the day, allowing no-injury medical monitoring claims would convert speculative fear into a legally compensable condition—and that’s a recipe for chaos. Let’s leave hypothetical harms where they belong–late-night WebMD spirals—not the courtroom.

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This post sort of got away from us.  We started with the proposition that our prescription medical product clients frequently move to dismiss cases, and thus seek to get courts to take judicial notice of FDA-related documents in product liability litigation involving their products.  Judicial notice in cases involving FDA regulated products can be of great assistance on pleadings-based motions (Rule 12(b)(6) and judgment on the pleadings) because judicial notice is an exception to the usual limitation of such motions to what plaintiffs plead – or, equally importantly, fail to plead – in their complaints.  Not only do judicially noticeable documents fill in facts that plaintiffs deliberately omit, but they can also defeat contrary factual allegations that the documents establish are untrue.  This is an important exception to the Rule 12 mantra that challenged allegations are to be taken as true.  Instead, allegations in a complaint are not credited where contradicted by judicially noticeable documents.  E.g., Fuqua v. Santa Fe County Sheriff’s Office, ___ F.4th ___, 2025 WL 3072794, at *4 (10th Cir. Nov. 4, 2025); Jeffery v. City of New York, 113 F.4th 176, 179 (2d Cir. 2024); Clark v. Stone, 998 F.3d 287, 298 (6th Cir. 2021); Massey v. Ojaniit, 759 F.3d 343, 353 (4th Cir. 2014); Kaempe v. Myers, 367 F.3d 958, 963 (D.C. Cir. 2004); Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir. 2001).  So judicial notice can overcome contrary pleadings.

Continue Reading Getting Noticed – Receiving FDA-Related Judicial Notice
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Removal-rama continues.  Art (if that is what you can call blogposting) mimics life. We have not just been blogging about removal cases lately, we’ve also been removing cases to federal court with startling frequency. And it’s been working. Twice, even with a removal basis that might be characterized as a jump ball, plaintiffs have not even bothered to file for remand to state court. That outcome almost certainly redounds to the benefit of our client. The lesson? Be brave.  It also helps to be right. 

But sometimes even being right might not be enough. In Brown v. Johnson & Johnson, 2025 U.S. Dist. LEXIS 231014, 2025 WL 3268408 (N.D. Cal. Nov. 24, 2025), the federal court incorrectly entered a remand order based on rejection of a “fraudulent joinder” argument. The plaintiff sued one of many related entities to defeat diversity and evidently picked the wrong one.  But the court was not sure it was the wrong entity, and, in any event, it looked like some other unsued entities might not be wrong. The plaintiff might be able to add those nondiverse parties, and somehow that concatenation of mights resulted in the case getting remanded. If that concatenation sounds a little sloppy, maybe even crazy, come sit right down beside us. 

The plaintiffs in Brown brought a lawsuit in a notoriously plaintiff-friendly jurisdiction, Alameda County, California, alleging that certain medications caused them to develop breast cancer.  The defendants included several drug maker defendants, all non-California citizens. To defeat diversity, the plaintiffs also sued Kaiser Permanente International. Kaiser is a California citizen, and its presence was the plaintiffs’ basis for avoiding federal court.  The defendants did not buy that basis, and removed the case to the Northern Disrict of California.  The defendants argued that Kaiser was solely a pharmacy, and relevant state law (California) seemed pretty clear that a pharmacy has a duty only to accurately fill prescriptions, and not to warn about the general risks of drugs.  Thus, Kaiser had been fraudulently joined, it should be dropped from the case, and the result would be complete diversity and federal jurisdiction. 

The plaintiffs disagreed. They filed a motion to remand the case to Alameda County. The plaintiffs argued that Kaiser insured them, treated them, and distributed the offending medications. Therefore, according to the plaintiffs, they had valid (or at least colorable) claims against Kaiser for strict liability failure to warn, general negligence, and negligent failure to warn. 

By now, we all know that the test for fraudulent joinder is tough, but that did not stop the Brown court from reminding us that “the question Is whether defendants have demonstrated that plaintiff could not possibly prevail on her claims against the allegedly fraudulently joined defendant.”  The burden is on the defense, and it is a heavy burden.

That being said, even if Kaiser is a large entity that does many things, it does not seem to have done the things that would make it liable for the claims alleged.  The plaintiffs seem to have been mistaken when they invited this partial Kaiser entity to the party. It is an understandable mistake, as there are several Kaiser entities. 

Did the Brown court decide that there might be a valid cause of action against the Kaiser entity that was actually sued?  Not really. The court did not even suggest that the failure to warn claims might apply to Kaiser.  But it hinted that a general negligence claim might stick. How?  Why?  We do not know. Instead, the court was won over by the plaintiffs’ that “even if” they cannot recover against that particular Kaiser entity, “they intend to amend their complaints to add other” similarly named entities.  Somehow, that possible amendment made the joinder of the Kaiser pharmacy non-fraudulent. Huh? Or to put things in rarefied legalese, so what? Isn’t the rule for removal purposes that the date of removal freezes the pleadings? That should mean that a promise or threat or idle speculation about filing an amended complaint in the future against some other defendant shouldn’t be enough to support remand.  Granted, the recent SCOTUS case of Royal Canin helped federal-fearing plaintiffs considerably by holding that post-removal amendments by plaintiffs could make diversity go away.  But at least in Royal Canin the plaintiff actually did the thing that obliterated diversity. In Brown, all we get is wish-casting. Mind you, we hate the holding in Royal Calin.  And now we hate the ruling in Brown. Even if plaintiffs are allowed to amend to defeat diversity in some circumstances, they had not done that in the Brown case.  It was the district court that did all the work — for bad reasons and in service of a bad result.  

(It’s almost as bad as a prosecutor getting an indictment by promising the grand jury that more and better evidence would be presented at trial. But that could never happen in our fair-minded republic — could it?)

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A few months ago we posted about how the Supreme Court’s decision in Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905) held up against challenges to COVID-19 vaccine mandates.  The decision—which upheld a smallpox vaccination order over 100 years ago—has fared very well. Jacobson’s recognition that “society based on the rule that each one is a law unto himself would soon be confronted with disorder and anarchy” applies today as much as it did in 1905. Id. at 26.  Today’s post addresses another COVID-19 decision relying on Jacobson to uphold vaccine mandates instituted for healthcare workers.  

Continue Reading Jacobson Remains Solid: Ninth Circuit Upholds Vaccine Mandate
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As many of the Blog’s authors and readers wake up today, they will be in New York for the ACI Drug and Medical Device Litigation Conference.  Clearly, the choice of venue matters when it comes to a conference.  It also matters to plaintiff lawyers and the medical product manufacturers that they sue.  The infamous list of judicial hellholes is typically comprised of courts where the plaintiff lawyers do what they can to bring and keep cases that could have been brought elsewhere.  For our part, we have devoted many posts to issues that affect where defendants are subject to suit, including general and specific personal jurisdiction, forum non conveniens, joinder, misjoinder, and removal.  For many of these, the question is often focused on whether one state or another, or the non-state federal courts, should have the case.  It is far less common that the issue is where in the state a case should proceed.  Because where in a state the plaintiff lives or lived at a relevant time point is often not hard to determine in a product liability case, the interesting part of venue fights still often comes down to misjoinder.  We know that the plaintiff lawyers like multi-plaintiff cases for a number of reasons, including anchoring a case in a particularly nasty part of state based on one of many plaintiffs.  We also know that the days when a Mississippi plaintiff, for instance, could sue in any county in her state—resulting in more pending cases than residents in some counties—are largely in the past.

In re AstraZeneca Pharms. LP, No. 15-25-00088-CV, 2025 WL 3251532 (Tex. App. Nov. 21, 2025) (“In re AZ”), presents a different venue issue based on the permissive language of the Texas version of the False Claims Act, the Texas Health Care Program Fraud Prevention Act (“THFPA,” not our acronym).  The result of In re AZ is that the defendant gets to move the case from Harrison County (home of Marshall) to Travis County (home of Austin) based on the granting of a mandamus petition by an intermediate appellate court after the trial court denied a motion to transfer.  While the direct applicability of the decision is pretty narrow, its analysis speaks to principles that come up in personal jurisdiction challenges.  The decision also makes us ponder about possible venue provisions in state product liability statutes.  We start with the pondering.  We are not sure such provisions would be preferrable compared to the current free-for-all.  Sometimes, but not always, specialized state courts that hear all the “mass torts” or a high percentage of the coordinated proceedings can be plaintiff-leaning.  They also tend to be in urban centers that, despite some on-going changes in jury dynamics, can match up with the aforementioned hell holes, past and present.  Other than existing consolidation procedures and existing procedural options for an in-state defendant to try to move a case to its home county, there is not an obvious default destination in each state for product liability cases.  The logic of the venue provision in the Texas mini-FCA statute is presumably that the state HHS in Austin is the recipient of any allegedly fraudulent claims for Medicaid payments.

In re AZ involved a claim from a relator that the defendant violated the THFPA based on state-wide schemes involving alleged “kickbacks” for certain of its medications.  The State of Texas declined to intervene, which, at least with the federal FCA, can be a sign that the case is a reach.  The plaintiff—we will use the familiar term and keep it singular—sued in Harrison County.  Why?  Probably for similar reasons that cases are brought there that seem more appropriate for other courts or venues.  The relatively small east Texas county—its population is about 1/20 that of Travis County based on the last census—has no obvious prominence when it comes to deciding an allegedly statewide issue focused on claims submitted to the state agency in Austin.  The THFPA includes a venue provision that allows cases to be brought in Travis County or “a county in which any part of the unlawful act occurred.”  2025 WL 3251532, *1.  Without detail, the complaint alleged that “[u]pon information and belief . . . [the defendant’s] unlawful acts occurred, in part, in Harrison County.”  Id.  In response to a motion to transfer, the plaintiff amended to add a paragraph alleging, in general terms, that defendant’s sales reps targeted unnamed providers affiliated with facilities in Harrison County.  In response to a renewed motion, plaintiff identified some content in a brochure about one of defendant’s drugs that was allegedly found in the county.  The trial court denied the transfer.

On mandamus, the denial was evaluated on an abuse of discretion standard.  The appellate court was not deprived of jurisdiction by a proposed second amended complaint or plaintiff’s desire to do discovery to support venue.  Simplifying Texas procedural issues a bit, the propriety of denying the motion to transfer is measured at the time of denial.  Id. at *3-4.  We will not say more about that or the rejection of plaintiff’s laches argument, except that the latter involved the irony of plaintiff claiming Austin was less convenient for trial than Marshall.  The more interesting part to us is the appellate court’s finding of an abuse of discretion because plaintiff failed to carry her burden “to present prima facie proof that any part of the alleged unlawful acts occurred in Harrison County.”  Id. at *6.  Plaintiff’s conclusory allegations in the live complaint were disputed by defendant, so plaintiff was required to offer actual evidence.  (It seems to us that the heightened pleading standard for a fraud-based claim should also mean that allegations of fraudulent acts in a particular place that is essential to venue cannot be vague and conclusory.)

Plaintiff first tried to say the defendants had sales reps furthering the alleged kickback schemes within the county, but she offered no actual evidence to support that.  Next, she pushed an argument similar to what we have seen in the personal jurisdiction context—that the ability for someone in Harrison County to access defendant’s websites meant that the allegedly unlawful acts had occurred in the county.  It is hard to see how maintaining a website could ever be seen as engaging in acts in each county in each state.  Rather than address the broader question, the In re AZ court determined that nothing on the defendant’s websites conveyed an “offer” that could be seen as fitting within the plaintiff’s theory of liability.  “At most, the websites represent a general invitation to apply for some of the challenged nurse services.”  Id. at *5 (internal quote omitted).  Plaintiff’s last argument was that the mere fact the aforementioned brochure was found in the county was enough to connect the defendant’s alleged scheme to the county.  However, the websites were still needed to get from the brochure to anything allegedly connected to the scheme and, of course, they contained no offers.  Thus, this was another dead end.

The result of all of this is that the case goes to Travis County.  Perhaps we have spilled too much virtual ink on this issue, but we know that venue can be determinative.  We also know that there are other cases brought under the THFPA that mirror product liability claims against drug and device companies (e.g., any claims submitted for the product were fraudulent because it was inherently worthless because of alleged contamination or risks).  Those cases also tend to get brought in some of the 254 counties in Texas the plaintiffs like most.

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